Cytarabine combined with Evoltra

Reports:

Reaction Outcome Event Date Age Sex Weight Reported Reporter Country Treatment
Role Name
Shock Hospitalization 3/1/2008 55 Female 4/14/2008
Primary
Secondary
Concomitant
Pyrexia Other Serious 1/28/2010 Male 2/18/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 1/28/2010 Male 2/19/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 1/28/2010 Male 3/22/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Bacteraemia Hospitalization 1/28/2010 46 Male 4/6/2010 Other Health Professional Italy
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 11/20/2008 4/20/2010 Physician France
Primary
Secondary
Concomitant
Toxic Encephalopathy Other Serious 11/20/2008 5/11/2010 Physician France
Primary
Secondary
Concomitant
Cardiotoxicity Life Threatening 2/8/2010 29 Male 187 lb 5/20/2010 Physician Turkey
Primary
Secondary
Sepsis Other Serious 3/2/2010 69 Male 143 lb 5/21/2010 Physician Germany
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 4/27/2010 53 Female 203 lb 5/25/2010 Physician Netherlands
Primary
Secondary
Concomitant
Disease Progression Death 2/23/2010 Female 110 lb 5/27/2010 Physician Austria
Primary
Concomitant
Peripheral Sensory Neuropathy Other Serious 4/28/2010 49 Female 119 lb 6/1/2010 Other Health Professional Belgium
Primary
Secondary
Thrombosis In Device Other Serious 5/3/2010 55 Male 419 lb 6/8/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Dermatitis Exfoliative Other Serious 5/21/2010 59 Male 163 lb 6/9/2010 Physician Netherlands
Primary
Secondary
Respiratory Failure Other Serious 4/27/2010 53 Female 203 lb 6/10/2010 Physician Netherlands
Primary
Secondary
Concomitant
Sepsis Life Threatening 1/18/2010 6/17/2010 Physician Bulgaria
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Death 2/23/2010 Female 110 lb 6/18/2010 Physician Austria
Primary
Concomitant
Pericarditis Infective Other Serious 5/3/2010 55 Male 419 lb 6/21/2010 Physician Netherlands
Primary
Secondary
Concomitant
Pericarditis Infective Other Serious 5/3/2010 55 Male 419 lb 7/1/2010 Physician Netherlands
Primary
Secondary
Concomitant
Myocardial Infarction Death 7/9/2010 Physician Italy
Primary
Secondary
Vomiting Other Serious 4/23/2010 49 Female 119 lb 7/9/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 34 Female 7/9/2010 Physician Italy
Primary
Secondary
Multi-organ Failure Other Serious 7/9/2010 Physician Italy
Primary
Secondary
Thrombocytopenia Other Serious 4/12/2010 67 Male 181 lb 7/13/2010 Physician Romania
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 4/12/2010 67 Male 181 lb 7/15/2010 Physician Romania
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/28/2010 57 Female 163 lb 7/22/2010 Physician Netherlands
Primary
Secondary
Concomitant
Sepsis Life Threatening 1/18/2010 7/28/2010 Physician Bulgaria
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/22/2010 57 Female 163 lb 8/4/2010 Physician Netherlands
Primary
Secondary
Concomitant
Vomiting Other Serious 4/23/2010 49 Female 119 lb 8/6/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 4/27/2010 53 Female 203 lb 8/27/2010 Physician Netherlands
Primary
Secondary
Concomitant
Sepsis Other Serious 2/3/2010 69 Male 143 lb 8/31/2010 Physician Germany
Primary
Secondary
Concomitant
Toxoplasmosis Life Threatening 8/20/2010 57 Male 163 lb 8/31/2010 Other Health Professional Netherlands
Primary
Secondary
Restlessness Life Threatening 7/10/2010 57 Male 163 lb 9/16/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 11/22/2008 62 Female 123 lb 9/20/2010 Physician Italy
Primary
Secondary
Septic Shock Other Serious 5/21/2009 48 Female 132 lb 9/20/2010 Physician Italy
Primary
Secondary
Concomitant
Human Herpesvirus 6 Infection Other Serious 2/6/2009 33 Female 146 lb 9/20/2010 Physician Italy
Primary
Secondary
Concomitant
Dermatitis Exfoliative Other Serious 5/21/2010 59 Male 163 lb 9/28/2010 Physician Netherlands
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/21/2010 57 Female 163 lb 9/29/2010 Physician Netherlands
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 9/12/2010 41 Male 185 lb 9/29/2010 Physician Netherlands
Primary
Secondary
Restlessness Other Serious 7/10/2010 57 Male 163 lb 10/1/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Bone Marrow Failure Other Serious 8/1/2010 34 Male 194 lb 10/18/2010 Physician France
Primary
Secondary
Concomitant
Acute Lymphocytic Leukaemia Death 10/11/2010 8 Male 65 lb 10/19/2010 Other Health Professional Korea, Republic Of
Primary
Secondary
Concomitant
Dermatitis Exfoliative Other Serious 5/21/2010 59 Male 163 lb 10/20/2010 Physician Netherlands
Primary
Secondary
Concomitant
Pneumonia Other Serious 10/22/2010 Physician Italy
Primary
Secondary
Staphylococcal Infection Other Serious 7/28/2010 34 Male 194 lb 10/22/2010 Physician France
Primary
Secondary
Concomitant
Septic Shock Other Serious 10/12/2010 57 Male 231 lb 10/28/2010 Physician Netherlands
Primary
Secondary
Concomitant
Pyrexia Other Serious 5/21/2010 57 Female 163 lb 10/29/2010 Physician Netherlands
Primary
Secondary
Concomitant
Thrombosis Life Threatening 10/19/2010 47 Female 115 lb 10/29/2010 Physician Netherlands
Primary
Secondary
Concomitant
Pulmonary Oedema Other Serious 10/24/2010 65 Male 174 lb 11/4/2010 Physician Switzerland
Primary
Secondary
Concomitant
Staphylococcal Infection Other Serious 7/28/2010 34 Male 194 lb 11/8/2010 Physician France
Primary
Secondary
Concomitant
Arrhythmia Life Threatening 11/2/2010 45 Male 265 lb 11/9/2010 Physician Netherlands
Primary
Secondary
Concomitant
Cerebral Haemorrhage Other Serious 11/2/2010 60 Male 159 lb 11/9/2010 Physician Netherlands
Primary
Secondary
Concomitant
Lung Infection Life Threatening 10/21/2010 43 Female 11/16/2010 Physician Netherlands
Primary
Secondary
Streptococcal Bacteraemia Other Serious 11/7/2010 61 Male 146 lb 11/19/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Skin Disorder Hospitalization 9/19/2010 65 Male 159 lb 11/19/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Septic Shock Life Threatening 11/2/2010 45 Male 265 lb 11/22/2010 Physician Switzerland
Primary
Secondary
Concomitant
Septic Shock Other Serious 10/12/2010 57 Male 231 lb 11/22/2010 Physician Netherlands
Primary
Secondary
Concomitant
Thrombosis Life Threatening 10/19/2010 47 Female 115 lb 11/23/2010 Physician Netherlands
Primary
Secondary
Concomitant
Respiratory Failure Life Threatening 8/7/2010 Female 11/23/2010 Physician Netherlands
Primary
Secondary
Concomitant
Pleural Effusion Other Serious 10/26/2010 60 Male 159 lb 11/24/2010 Physician Netherlands
Primary
Secondary
Concomitant
Skin Toxicity Hospitalization 9/19/2010 65 Male 159 lb 11/24/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Renal Failure Other Serious 11/10/2010 24 Female 128 lb 11/24/2010 Physician Netherlands
Primary
Secondary
Concomitant
Septic Shock Other Serious 10/12/2010 57 Male 231 lb 11/24/2010 Physician Netherlands
Primary
Secondary
Concomitant
Sudden Death Hospitalization 11/3/2010 57 Male 137 lb 11/24/2010 Other Health Professional Belgium
Primary
Secondary
Pulmonary Oedema Other Serious 10/12/2010 65 Male 174 lb 11/29/2010 Physician Switzerland
Primary
Secondary
Concomitant
Pancytopenia Life Threatening 9/17/2010 65 Female 132 lb 11/29/2010 Physician Netherlands
Primary
Secondary
Hypokalaemia Other Serious 11/21/2010 63 Male 164 lb 12/2/2010 Consumer Netherlands
Primary
Secondary
Pulmonary Oedema Other Serious 10/12/2010 65 Male 174 lb 12/6/2010 Physician Switzerland
Primary
Secondary
Concomitant
Septic Shock Other Serious 10/12/2010 57 Male 231 lb 12/7/2010 Physician Netherlands
Primary
Secondary
Concomitant
Sepsis Other Serious 10/21/2010 46 Female 12/8/2010 Physician Netherlands
Primary
Secondary
Concomitant
Renal Failure Other Serious 10/20/2010 24 Female 128 lb 12/9/2010 Physician Netherlands
Primary
Secondary
Concomitant
Multi-organ Failure Other Serious 4/23/2009 7 Female 40 lb 12/13/2010 Physician Hungary
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 11/21/2010 63 Male 164 lb 12/13/2010 Consumer Netherlands
Primary
Secondary
Nephrolithiasis Hospitalization 11/30/2010 48 Female 121 lb 12/13/2010 Physician Switzerland
Primary
Secondary
Concomitant
Pulmonary Oedema Life Threatening 10/24/2010 65 Male 174 lb 12/13/2010 Physician Switzerland
Primary
Secondary
Concomitant
Bone Marrow Failure Hospitalization 11/30/2010 58 Male 159 lb 12/16/2010 Physician Netherlands
Primary
Secondary
Skin Disorder Hospitalization 9/19/2010 65 Male 159 lb 12/16/2010 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Myocardial Ischaemia Other Serious 12/2/2010 64 Female 154 lb 12/16/2010 Physician Netherlands
Primary
Secondary
Pancytopenia Life Threatening 9/17/2010 65 Female 154 lb 12/17/2010 Physician Netherlands
Primary
Secondary
Thrombocytopenia Other Serious 12/6/2010 39 Female 152 lb 12/23/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Sepsis Life Threatening 11/2/2010 45 Male 265 lb 12/27/2010 Physician Switzerland
Primary
Secondary
Concomitant
Thrombocytopenia Other Serious 12/6/2010 39 Female 152 lb 12/29/2010 Other Health Professional Belgium
Primary
Secondary
Concomitant
Respiratory Failure Other Serious 11/21/2010 63 Male 164 lb 12/29/2010 Physician Netherlands
Primary
Secondary
Transaminases Increased Other Serious 8/23/2010 20 Female 104 lb 12/30/2010 Physician France
Primary
Concomitant
Multi-organ Failure Other Serious 4/23/2009 7 Female 40 lb 12/30/2010 Physician Hungary
Primary
Secondary
Concomitant
Delirium Other Serious 5/21/2010 57 Female 163 lb 1/3/2011 Physician Netherlands
Primary
Secondary
Concomitant
Febrile Neutropenia Other Serious 10/26/2010 60 Male 159 lb 1/4/2011 Physician Netherlands
Primary
Secondary
Concomitant
Streptococcal Infection Hospitalization 11/17/2010 48 Female 157 lb 1/4/2011 Physician Belgium
Primary
Secondary
Pancytopenia Hospitalization 11/30/2010 58 Male 159 lb 1/5/2011 Physician Netherlands
Primary
Secondary
Multi-organ Failure Life Threatening 11/25/2010 63 Male 164 lb 1/5/2011 Physician Netherlands
Primary
Secondary
Pulmonary Haemorrhage Hospitalization 11/3/2010 57 Male 137 lb 1/5/2011 Other Health Professional Belgium
Primary
Secondary
Respiratory Failure Life Threatening 10/25/2010 46 Female 1/5/2011 Physician Netherlands
Primary
Secondary
Concomitant
Sepsis Hospitalization 11/2/2010 45 Male 265 lb 1/11/2011 Physician Switzerland
Primary
Secondary
Concomitant
Hepatomegaly Other Serious 8/20/2010 57 Male 163 lb 1/14/2011 Other Health Professional Netherlands
Primary
Secondary
Concomitant
Renal Abscess Other Serious 12/6/2010 58 Male 265 lb 1/17/2011 Other Health Professional Netherlands
Primary
Secondary
Pancytopenia Life Threatening 11/15/2010 59 Male 209 lb 1/17/2011 Physician Netherlands
Primary
Secondary
Nephrolithiasis Hospitalization 11/30/2010 48 Female 121 lb 1/17/2011 Physician Switzerland
Primary
Secondary
Concomitant
Encephalopathy Life Threatening 11/2/2010 45 Male 243 lb 1/19/2011 Physician Switzerland
Primary
Secondary
Concomitant
Delirium Life Threatening 9/12/2010 41 Male 185 lb 1/20/2011 Physician Netherlands
Primary
Secondary
Concomitant
Leukaemia Death 12/1/2010 14 Male 83 lb 1/24/2011 Physician Netherlands
Primary
Secondary
Gastrointestinal Necrosis Death 10/20/2010 24 Female 128 lb 1/27/2011 Physician Netherlands
Primary
Secondary
Concomitant
Bronchopulmonary Aspergillosis Other Serious 12/6/2010 39 Female 152 lb 1/27/2011 Other Health Professional Belgium
Primary
Secondary
Concomitant
Febrile Neutropenia Death 10/26/2010 60 Male 159 lb 2/1/2011 Physician Netherlands
Primary
Secondary
Concomitant
Neutropenic Colitis Death 10/24/2010 65 Male 174 lb 2/1/2011 Physician Switzerland
Primary
Secondary
Concomitant
Cerebral Haemorrhage Life Threatening 1/24/2011 49 Male 225 lb 2/1/2011 Other Health Professional Belgium
Primary
Secondary
Encephalitis Hospitalization 9/6/2010 38 Female 2/3/2011 Other Health Professional France
Primary
Secondary
Concomitant
Anal Abscess Hospitalization 1/18/2011 44 Male 172 lb 2/7/2011 Physician Netherlands
Primary
Secondary
Concomitant
Renal Failure Other Serious 10/20/2010 24 Female 128 lb 2/9/2011 Physician Netherlands
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 11/30/2010 58 Male 159 lb 2/9/2011 Physician Netherlands
Primary
Secondary
Multi-organ Failure Death 11/25/2010 63 Male 164 lb 2/9/2011 Physician Netherlands
Primary
Secondary
Nephrolithiasis Other Serious 11/13/2010 48 Female 121 lb 2/11/2011 Physician Switzerland
Primary
Secondary
Concomitant
Abdominal Pain Death 1/24/2011 49 Male 225 lb 2/14/2011 Other Health Professional Belgium
Primary
Secondary
Pancytopenia Hospitalization 11/30/2010 58 Male 159 lb 2/15/2011 Physician Netherlands
Primary
Secondary
Anal Abscess Hospitalization 1/18/2011 44 Male 172 lb 2/22/2011 Consumer Netherlands
Primary
Secondary
Concomitant
Off Label Use Hospitalization 3/8/2011 Physician France
Primary
Secondary
Concomitant
Pancytopenia Other Serious 38 Male 3/10/2011 Physician Spain
Primary
Secondary
Death Other Serious 35 Male 3/10/2011 Physician Spain
Primary
Secondary
Deep Vein Thrombosis Death 1/1/2010 61 Female 3/11/2011 Physician Netherlands
Primary
Secondary
Concomitant
Neutropenia Other Serious 12/6/2010 39 Female 163 lb 3/15/2011 Other Health Professional Belgium
Primary
Secondary
Concomitant
Pancytopenia Hospitalization 11/30/2010 58 Male 159 lb 3/17/2011 Physician Netherlands
Primary
Secondary
Bronchopulmonary Aspergillosis Hospitalization 11/2/2010 45 Male 243 lb 3/18/2011 Physician Switzerland
Primary
Secondary
Concomitant
Multi-organ Failure Hospitalization 10/20/2010 24 Female 128 lb 3/21/2011 Physician Netherlands
Primary
Secondary
Concomitant
Pulmonary Haemorrhage Hospitalization 11/3/2010 57 Male 137 lb 3/24/2011 Other Health Professional Belgium
Primary
Secondary
Febrile Neutropenia Other Serious 12/2/2010 64 Female 154 lb 3/28/2011 Physician Netherlands
Primary
Secondary
Haemoglobin Decreased Other Serious 1/20/2011 60 Female 134 lb 4/5/2011 Physician United Kingdom
Primary
Secondary
Febrile Neutropenia Other Serious 12/2/2010 64 Female 154 lb 4/14/2011 Physician Netherlands
Primary
Secondary
Pulmonary Fibrosis Other Serious 1/27/2011 58 Female 115 lb 4/15/2011 Other Health Professional Belgium
Primary
Secondary
Systemic Candida Death 12/11/2010 45 Male 179 lb 4/22/2011 Physician Belgium
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 1/20/2011 60 Female 134 lb 4/22/2011 Consumer United Kingdom
Primary
Secondary
Neurotoxicity Hospitalization 4/6/2011 64 Male 165 lb 4/25/2011 Physician Netherlands
Primary
Secondary
Thrombocytopenia Life Threatening 18 Male 4/19/2011 Other Health Professional United Kingdom
Primary
Secondary
Chills Other Serious 4/4/2011 59 Female 154 lb 4/29/2011 Physician Belgium
Primary
Secondary
Concomitant
Perirectal Abscess Hospitalization 3/31/2011 56 Male 229 lb 5/2/2011 Physician France
Primary
Secondary
Concomitant
Neurotoxicity Hospitalization 4/6/2011 64 Male 165 lb 5/5/2011 Physician Netherlands
Primary
Secondary
Concomitant
Respiratory Failure Hospitalization 4/18/2011 63 Male 245 lb 5/5/2011 Consumer Netherlands
Primary
Secondary
Concomitant
Toxicity To Various Agents Other Serious 4/4/2011 59 Female 154 lb 5/5/2011 Other Health Professional Belgium
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Hospitalization 9/6/2010 38 Female 5/10/2011 Other Health Professional France
Primary
Secondary
Concomitant
Septic Shock Other Serious 1/27/2011 58 Female 115 lb 5/13/2011 Physician Belgium
Primary
Secondary
Neurotoxicity Hospitalization 4/6/2011 64 Male 165 lb 5/18/2011 Physician Netherlands
Primary
Secondary
Concomitant
Septic Shock Death 5/1/2010 57 Female 5/23/2011 Physician Hungary
Primary
Secondary
Leukaemia Hospitalization 12/1/2010 14 Male 83 lb 5/23/2011 Physician Netherlands
Primary
Secondary
Liver Function Test Abnormal Hospitalization 11/11/2010 48 Female 121 lb 5/25/2011 Physician Switzerland
Primary
Secondary
Concomitant
Hepatotoxicity Other Serious 8/23/2010 20 Female 104 lb 5/27/2011 Physician France
Primary
Concomitant
Pulmonary Haemorrhage Hospitalization 4/12/2011 54 Male 126 lb 5/28/2011 Other Health Professional Switzerland
Primary
Secondary
Concomitant
Atrial Fibrillation Other Serious 5/10/2011 50 Male 5/28/2011 Physician United Kingdom
Primary
Secondary
Concomitant
Transient Psychosis Hospitalization 4/30/2011 63 Male 192 lb 5/31/2011 Consumer Germany
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 5/11/2011 52 Female 5/31/2011 Physician United Kingdom
Primary
Secondary
Traumatic Lung Injury Life Threatening 4/12/2011 54 Male 126 lb 6/6/2011 Physician Netherlands
Primary
Secondary
Concomitant
Acute Myeloid Leukaemia Recurrent Death 5/11/2011 52 Female 6/10/2011 Other Health Professional United Kingdom
Primary
Secondary
Dehydration Hospitalization 4/7/2010 61 Female 6/10/2011 Physician Netherlands
Primary
Secondary
Concomitant

Drug Data